Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 1:21 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT02472795
Description: None
Frequency Threshold: 1
Time Frame: All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
Study: NCT02472795
Study Brief: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cenerimod 0.5 mg Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. 0 None 0 12 5 12 View
Cenerimod 1 mg Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. 0 None 0 12 5 12 View
Cenerimod 2 mg Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. 0 None 0 13 6 13 View
Cenerimod 4 mg Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. 0 None 0 13 5 13 View
Matching Placebo Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. 0 None 1 17 9 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis chronic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Post cholecystectomy syndrome NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Age-related macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Dry age-related macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastroduodenitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Chronic hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Asymptomatic bacteriuria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tracheobronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Bilirubin conjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood fibrinogen decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood potassium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Electrocardiogram T wave amplitude decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Intraocular pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Laboratory test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Type 2 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Nitrituria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Nail dystrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Tooth extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View